AgingHEALNCT03827499
HMB Supplementation in Addition to Multicomponent Exercise in Old Adults
A study testing HMB dietary supplementation and Multicomponent physical exercise program in people with Aging and Frail Elderly Syndrome, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Frail Elderly Syndrome, Physical Activity
- What is being tested?
- HMB dietary supplementation and Multicomponent physical exercise program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women aged ≥70 years living in a nursing home
- Be able to follow an active physical rehabilitation program
- Be able to read and wright
- Voluntary participation
- Capable and willing to provide an informed consent
Who cannot join
- Acute heart attack (recent 3-6 months) or unstable angina
- Uncontrolled atrial or ventricular arrhythmias
- Aortic dissecting aneurysm
- Severe aortic stenosis
- Acute endocarditis / pericarditis
- Uncontrolled high blood pressure (>180/100 mmHg)
Show all 20Show fewer
- Acute thromboembolism
- Acute or severe heart failure
- Acute or severe respiratory failure
- Uncontrolled postural hypotension
- Uncontrolled acute decompensated diabetes mellitus or low blood sugar
- A recent fracture in the last month.
- Coincident participation in any intervention trial
- HMB contraindication, intolerance, or allergy
- Community-dwelling people
- Have regularly performed exercise (>20 minutes >3 days/week) in the last 3 months
- Malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in situ of the uterine cervix)
- Revascularization within 1 year
- Severe loss of vision, hearing, or communicative ability
- Conditions preventing cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.
Read the detailed description
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown.
Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.
The findings of the HEAL study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.
- Conditions
- Aging, Frail Elderly Syndrome, Physical Activity
- Being tested
- HMB dietary supplementation, Multicomponent physical exercise program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB dietary supplementationDietary supplement
Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention
Multicomponent physical exercise programOther
Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ex-HMB | Experimental | HMB dietary supplementation and Multicomponent physical exercise program Receives: Dietary Supplement: HMB dietary supplementation; Other: Multicomponent physical exercise program |
| NoEx-HMB | Experimental | HMB Dietary supplementation Receives: Dietary Supplement: HMB dietary supplementation |
| Ex-Plac | Placebo comparator | Multicomponent physical exercise program Receives: Other: Multicomponent physical exercise program |
| Controls | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
Summary scores range from 0-12 and higher scores denote higher physical performance.
Measured: Baseline to 25 Weeks
Secondary outcomes (15)
Change in Handgrip strength (kg)
Using a dynamometer
Measured: Baseline to 25 Weeks
Change in lower-body strength (kg)
Seated leg press one-repetition maximun test
Measured: Baseline to 25 Weeks
Change in upper-body strength (kg)
Vertical bench press one-repetition maximun test
Measured: Baseline to 25 Weeks
Change in lower-body strength power output (m/s)
Seated leg press load-velocity profile
Measured: Baseline to 25 Weeks
Change in upper-body strength power output (m/s)
Vertical bench press load-velocity profile
Measured: Baseline to 25 Weeks
Change in frailty (score)
Frailty phenotype determination using Fried's criteria
Measured: Baseline to 25 Weeks
Change in lean body mass (kg)
Change in lean body mass using dual energy x-ray absorptiometry
Measured: Baseline to Week 25
Change in lipid profile
Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)
Measured: Baseline to Week 25
Change in glycaemic profile
Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)
Measured: Baseline to Week 25
Change in Thyroid-Stimulating Hormone (mIU/L)
Measured: Baseline to Week 25
Change in Disability (Lawton index scores)
Disability in instrumental activities of daily living.
Measured: Baseline to 25 Weeks
Change in Disability (Barthel index scores)
Disability in basic activities of daily living
Measured: Baseline to 25 Weeks
Change in Comorbidity (score)
When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes
Measured: Baseline to 25 Weeks
Change in cognitive function (score)
Using the Mini-Mental State Examination
Measured: Baseline to 25 Weeks
Change in depression (score)
Using the 15-item Yesavage geriatric depression
Measured: Baseline to 25 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start30 Mar 2019
- Primary completion30 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Courel Ibáñez, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827499
- Sponsor's protocol ID
- 2131/2018
- Acronym
- HEAL
- Status last verified
- May 2023
- First submitted
- 30 Jan 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Courel-Ibanez J, Pallares JG; HEAL study group. Effects of beta-hydroxy-beta-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. BMC Geriatr. 2019 Jul 5;19(1):188. doi: 10.1186/s12877-019-1200-5.
PubMed 31277595
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
- ClinicalTrials.gov ID
- NCT03827499
- Acronym / sponsor ID
- HEAL / 2131/2018
- Conditions
- Aging, Frail Elderly Syndrome, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.
Detailed description
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown.
Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.
The findings of the HEAL study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ex-HMB | Experimental | Dietary Supplement: HMB dietary supplementation, Other: Multicomponent physical exercise programHMB dietary supplementation and Multicomponent physical exercise program |
| NoEx-HMB | Experimental | Dietary Supplement: HMB dietary supplementationHMB Dietary supplementation |
| Ex-Plac | Placebo comparator | Other: Multicomponent physical exercise programMulticomponent physical exercise program |
| Controls | No intervention | –No intervention |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Men and women aged ≥70 years living in a nursing home
- Be able to follow an active physical rehabilitation program
- Be able to read and wright
- Voluntary participation
- Capable and willing to provide an informed consent
Key exclusion criteria (20 listed)
- Acute heart attack (recent 3-6 months) or unstable angina
- Uncontrolled atrial or ventricular arrhythmias
- Aortic dissecting aneurysm
- Severe aortic stenosis
- Acute endocarditis / pericarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMB dietary supplementationIntervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention | Dietary supplement | Ex-HMB, NoEx-HMB |
| Multicomponent physical exercise programIntervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks. | Other | Ex-HMB, Ex-Plac |
Primary outcome
Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
Time frame: Baseline to 25 Weeks
Summary scores range from 0-12 and higher scores denote higher physical performance.
15 secondary outcomes
Change in Handgrip strength (kg)
Time frame: Baseline to 25 Weeks
Change in lower-body strength (kg)
Time frame: Baseline to 25 Weeks
Change in upper-body strength (kg)
Time frame: Baseline to 25 Weeks
Change in lower-body strength power output (m/s)
Time frame: Baseline to 25 Weeks
Change in upper-body strength power output (m/s)
Time frame: Baseline to 25 Weeks
Change in frailty (score)
Time frame: Baseline to 25 Weeks
Change in lean body mass (kg)
Time frame: Baseline to Week 25
Change in lipid profile
Time frame: Baseline to Week 25
Change in glycaemic profile
Time frame: Baseline to Week 25
Change in Thyroid-Stimulating Hormone (mIU/L)
Time frame: Baseline to Week 25
Change in Disability (Lawton index scores)
Time frame: Baseline to 25 Weeks
Change in Disability (Barthel index scores)
Time frame: Baseline to 25 Weeks
Change in Comorbidity (score)
Time frame: Baseline to 25 Weeks
Change in cognitive function (score)
Time frame: Baseline to 25 Weeks
Change in depression (score)
Time frame: Baseline to 25 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 31277595Courel-Ibanez J, Pallares JG; HEAL study group. Effects of beta-hydroxy-beta-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. BMC Geriatr. 2019 Jul 5;19(1):188. doi: 10.1186/s12877-019-1200-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB dietary supplementation and Multicomponent physical exercise program in people with Aging and Frail Elderly Syndrome, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score (time frame: Baseline to 25 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.